Dry glassy composition comprising a bioactive material

Abstract

The present invention relates to formulations and methods for stabilizing and protecting of biologic materials during harsh storing and use conditions, wherein the formulations relate to embedded bioactive materials and biologics, including live bacteria, in a protective glassy matrix.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application claims priority to U.S. Provisional Application No. 61 / 299,315 filed in the United States Patent and Trademark Office on Jan. 28, 2010, the content of which is hereby incorporated by reference herein for all purposesBACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention relates to stabilizing and protecting of biologic materials during harsh storing and use conditions, and more particularly, the invention relates to embedding bioactive materials and biologics including live bacteria in a protective formulation of an amorphous glassy matrix.[0004]2. Related Art[0005]Freeze-drying has traditionally been the most common method of preserving sensitive biological substances such as live or dead bacteria and viruses and proteins, whereas other methods such as spray drying, fluidized spray drying and desiccation are generally not suitable. The high drying temperatures used in these methods result in...

AI Technical Summary

Benefits of technology

[0023]In a preferred embodiment, the snap-frozen particles are immediately dried or otherwise stored in a deep freezer, preferably at −80° C., until drying. The frozen particles are then loaded on trays and immediately transferred to a vacuum drying chamber where they are dried according to the present invention. Preferably, the drying is initiated by subjecting the frozen particles under vacuum pressure between 0 and 2000 mTORR. The frozen particles are degassed and their structure and volume allowed to develop and stabilize for a short period of time. Typically, the desirable time period for subjecting the frozen particle to high vacuum pressure is no more than 30 minutes, more preferably the time period is between 1 and 20 min. After the short initial degassing and structure stabilizing of the frozen particles the vacuum is adjusted to between 2000 and 10,000 mTORR and heat applied t

Problems solved by technology

Freeze-drying has traditionally been the most common method of preserving sensitive biological substances such as live or dead bacteria and viruses and proteins, whereas other methods such as spray drying, fluidized spray drying and desiccation are generally not suitable.

The high drying temperatures used in these methods result in significant damage to the bioactive material itself.

In addition, they may not sufficiently dry the material to the specific residual moisture or water activity requirements for product stability, and thus an additional drying step by other means, may be required.

Often the freeze drying process results in a significant loss of activity and damage to the bioactive material due to the formation of ice crystals during the slow drying process.

Furthermore, the freezing step itself, if not done correctly, can denatured or inactivate the bioactive material.

However, such protective agents may not penetrate adequately into the cell to protect active components within the intracellular volume which may lead to instability upon storage of the freeze-dried substances.

For this reason, membranous biomaterials such as viruses, bacteria, and cells do not survive well in freeze-drying process.

Therefore, a significant challenge remains to develop an optimal drying process and formulation that minimizes drying losses while achieving adequate storage stability of the dried material.

Many glasses fail to stabilize because they react with the bioactive material during storage.

Obvious problems occur with reducing sugars, which may form good physical glasses but then their aldehyde groups attack amino groups on the bioactive in a typical Maillard reaction, whereas non-reactive sugars give stable products, which require no refrigeration at all.

Since sugars are inherently hygroscopic, water removal and final drying of the supersaturated syrup become extremely

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